Contraceptive Device; Intrauterine Clinical Trial
Official title:
Discontinuation Rates Among Copper Intrauterine Device Users in Primary Healthcare Unit and University Clinic. Is There a Difference?
The intrauterine device (IUD) is one of the most widely used reversible, long-term contraceptive methods in the world. But despite all its advantages; discontinuation rate of IUD ranged from 9.6% to 37.3 % (according to Demographic and Health Surveys data). In Egypt, in 2014, the discontinuation rate of IUD (within 12 months of use) was 14.3%.This study explores the differences around this rate in Egyptian university clinic and primary healthcare clinic with detailed percentages of possible causes.
The aim of the study is to compare between primary health care unit and university family
planning clinic in discontinuation rate among copper IUD users.
1. The Research Hypothesis: (Null hypothesis) • In women using copper IUD, discontinuation
rate in primary health care unit and university clinic may be similar.
2. The Research Question:
- In women using copper IUD, Does discontinuation rate in primary health care unit
and university clinic differ?
3. METHODOLOGY:
Patients and Methods
- Study setting:
o Family planning Outpatient clinic of Ain Shams Maternity Hospital, (ASUMH)
o primary health care unit in ain shams area
- Study population:
o Study period: 1 year
o Sample size: was calculated using Sample size computer program 11. After review of
literature, no previous similar study was done before, so assume a discontinuation rate
of 50% among Cu-IUD users in primary healthcare unit and 25% among Cu-IUD users in
university clinic. Based on these values; the study will include 170 Cu-IUD users;
equally selected as 85 subjects from each clinic. But due to the expected drop outs,
recruitment will start by 200 women from each clinic.
- Statistics:
- Descriptive statistics for measured variables will be expressed as range, mean and
standard deviation (for metric data); range, median and interquartile range (for
discrete data); and number and proportions (for categorical data). Cu-IUD
discontinuation findings in each clinic will be compared using the t-test or the
Mann-whitney U test depending on whether the measured parameters are guassian
variables. A P-value of 0.05 or less will be considered statistically significant.
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